Manager, Europe/International Quality Operations and EU QP
Azurity Pharmaceuticals - Ireland
Salary undisclosed
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Description
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure full compliance with EU GMP and GDP regulations. In addition to core EU responsibilities, this role will support global quality operations including CMO oversight, deviation & CAPA management, change control, audits, and technical batch release.
Principle Responsibilities:
EU QP
- Certify and release commercial and clinical batches in accordance with EU GMP (Directive 2001/83/EC and 2001/20/EC).
- Ensure product compliance with Marketing Authorizations and Manufacturing & Import Authorization (MIA) requirements.
- Hoste regulatory inspections from HPRA, manage follow-up actions, and liaise with EU authorities.
- Engage in EU Quality Management System: deviation & CAPA handling, change control, product quality reviews, and risk assessments.
- Support review or/and conducting GMP/GDP audits of CMOs, 3PLs, and contract labs within the EU.
- Support continuous improvement and training of QA personnel related to EU compliance requirements.
Quality Operations
- Provide QA oversight for CMOs based in EU/EEA/RoW, including deviation & CAPA assessment, change control management.
- Conduct and/or review quality audits for facilities and service providers.
- Assess technical documentation for batch disposition (e.g. CoA/CoCs, artwork, deviation investigation reports, stability data) to support in-market product release.
- Ensure quality processes align with international standards and local market requirements.
- Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
Qualifications and Education Requirements
- Must meet the HPRA criteria to act as EU QP under EU legislation.
- Degree in pharmacy, chemistry, or biology.
- Minimum 8 years in pharmaceutical QA.
- Previous experience as a QP or Deputy QP.
- Experience with HPRA inspections is beneficial.
#LI-Hybrid
About this role
Azurity Pharmaceuticals Ireland is recruiting a Qualified Person to anchor EU regulatory compliance and lead a dual-focused quality operations role. You would serve as the official EU QP responsible for batch certification and release under GMP directives, manage HPRA inspections and regulatory correspondence, and oversee the company's quality management system across deviations, CAPAs, and change controls. Beyond these core EU responsibilities, you would extend quality oversight to contract manufacturers and third-party logistics providers across multiple regions, assess technical documentation for batch disposition, and ensure alignment between quality processes and market-specific requirements.
The position demands someone already credentialed as a QP or Deputy QP with at least eight years in pharmaceutical quality assurance and a background in pharmacy, chemistry, or biology. HPRA inspection experience is valued. You would work hybrid from Dublin, collaborating across Supply Chain, Regulatory, and Technical Operations to support product release across diverse markets. This is a contract role suited to a quality professional ready to take on both the formal regulatory authority of an EU QP and the broader operational scope of international quality oversight.
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Pay for this role
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